Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
changing the possible for patients through engineered cells, today
reported financial results and business highlights for the second
quarter 2023.
“We continue to execute on our plans to deliver
clinical data using Sana’s hypoimmune (HIP) technology in two
studies later in 2023, providing insight into how the promising
preclinical HIP data translate into people,” said Steve Harr,
Sana’s President and Chief Executive Officer. “If the HIP
technology is effective in preventing rejection of allogeneic
cells, we believe it can rapidly translate into important
therapeutics for various blood cancers, B-cell mediated autoimmune
diseases, and type 1 diabetes. We are on track to advance our
emerging clinical pipeline and file multiple additional INDs this
year, and we have the balance sheet to enable multiple clinical
data readouts from our pipeline.”
Recent Corporate Highlights
Opportunity for clinical proof of
concept for two different first-in-human studies, each with the
potential for initial clinical data this year
- The ARDENT trial
evaluates SC291, an ex vivo hypoimmune-modified CD19-directed
allogeneic CAR T cell therapy, in patients with B-cell
malignancies. The goal of the hypoimmune platform is to overcome
the immunologic rejection of allogeneic cells, which, if successful
with SC291, may result in longer CAR T cell persistence and a
higher rate of durable complete responses for these patients.
- Enrollment in the ARDENT Phase 1 study
continued.
- SC291 has the potential to serve as
clinical proof-of-platform for other hypoimmune-modified CAR T cell
candidates using clinically-validated or commercially-approved CAR
constructs in development at Sana for hematological malignancies,
such as SC262 (CD22) and SC255 (BCMA). Sana’s goal is to file an
IND for SC262 later this year and for SC255 in 2024.
- Sana is developing SC451, a
hypoimmune-modified stem-cell derived islet cell therapy for
patients with type 1 diabetes. SC451, which is engineered with
Sana’s hypoimmune technology, has the potential to replace missing
islet cells without immunosuppression in persons with type 1
diabetes by evading allogeneic and autoimmune responses.
- Sana expects
initial data later this year from an investigator-sponsored trial
transplanting hypoimmune-modified primary human islet cells into
type 1 diabetes patients. The goal of the study is to show safety,
cell survival, immune evasion, and C-peptide production without the
need for immunosuppression.
- Sana’s goal is to file an IND for
SC451 in 2024.
Published preclinical data in
Nature Communications describing immune
evasion, persistence, and durable anti-tumor activity of Sana’s
hypoimmune-modified CD19-directed CAR T cells
- Sana developed
hypoimmune-modified CD19 targeted allogeneic CAR T cells and
compared them to unmodified CD19-targeted allogeneic CAR T cells in
a murine leukemia model with a humanized immune system.
- Although both
hypoimmune-modified and unmodified CAR T cells showed robust early
tumor killing, cell durability was much greater in humanized mice
treated with hypoimmune-modified cells. Hypoimmune-modified
allogeneic CAR T cells persisted and removed all evidence of tumor
for the duration of the study. Hypoimmune-modified CAR T cells also
cleared all evidence of tumor after re-injection with cancer cells
90 days into the study. In contrast and consistent with the
experience in patients to date, unmodified allogeneic CAR T cells
showed greatly reduced persistence and a high rate of tumor
recurrence in this model.
- These studies
provide additional insight for SC291 and the allogeneic hypoimmune
CAR T platform more broadly, including SC262 and SC255.
Published preclinical data in
Science Translational Medicine
demonstrating that Sana’s hypoimmune-modified pseudo-islets
control type 1 diabetes
- Sana developed
hypoimmune-modified human islet cells, which cluster into effective
endocrine organoids termed “pseudo islets” (p-islets) and studied
these p-islets in multiple preclinical models.
- Preclinical data
showed that p-islets survive, persist, escape allogeneic rejection,
and normalize blood glucose in diabetic models with humanized
immune systems.
- Two different
murine models showed that the hypoimmune-modified cells can evade
autoimmune rejection and normalize blood glucose. First, these
cells were studied in the standard model for autoimmunity in
diabetes. Second, Sana created a humanized mouse model with immune
cells from a diabetic person and transplanted pancreatic islet
cells derived from the diabetic person’s stem cells. In both cases,
unmodified pancreatic islet cells were rapidly cleared by the
immune system. In contrast, hypoimmune-modified pancreatic islet
cells survived, persisted, and provided sustained blood glucose
control in both models.
- These studies
provide additional insight for SC451 in persons with type 1
diabetes.
Published preclinical data in
Nature Biotechnology demonstrating that
Sana’s hypoimmune-modified cells survive allogeneic transplant
across several species, including non-human primates (NHPs) with
normal immune systems, and remain fully functional
- Sana developed
hypoimmune-modified NHP induced pluripotent stem cells (iPSCs) and
transplanted them into immunocompetent NHPs. Results were compared
to transplantation of unmodified iPSCs into immunocompetent
NHPs.
- Data showed that
hypoimmune-modified iPSCs survived for the duration of the study
(16 weeks), while unmodified iPSCs disappeared within two weeks.
There was an antibody and T cell response directed toward
unmodified cells, but not hypoimmune-modified cells.
- Hypoimmune-modified
primary NHP pancreatic islet cells survived 40 weeks (duration of
the study) after allogeneic transplantation into an immunocompetent
NHP versus less than one week for unmodified primary islet
cells.
- Hypoimmune-modified
iPSCs were differentiated into pancreatic islet cells.
Transplantation of hypoimmune-modified iPSC-derived pancreatic
cells into allogeneic diabetic mice with a humanized immune system
showed immune evasion after transplantation for the duration of the
studies (4 weeks) and amelioration of diabetes and normalization of
blood glucose levels.
Presented multiple abstracts at several
medical conferences, including AACR, ASGCT, and ISSCR 2023,
highlighting both the hypoimmune and fusogen platforms
- ISSCR:
- Presented
preclinical data showing that hypoimmune-modified CD19-directed CAR
T cells have the potential to serve as a universal off-the-shelf
therapy with long-term durability of response without
immunosuppression.
- Presented
preclinical data showing HIP-modified primary pancreatic islet
cells alleviate diabetes in humanized mice and avoid immune
rejection without immunosuppression.
- Presented
preclinical data showing that intramuscular administration of islet
cells in humanized mice does not impact cell function and viability
and may serve as a preferred administration route for
patients.
- Presented
preclinical data showing in vivo delivery of genetic payloads to
human hematopoietic stem/progenitor cells.
- ASGCT:
- Presented
preclinical data demonstrating a novel technique to detect
peripheral blood CAR+ T cells.
- Presented
preclinical data demonstrating cell-specific transduction, CAR
expression, and target cell killing, which supports the safety of
in vivo administration of Sana’s novel CD8-targeted fusosomes for
CAR T therapies.
- Presented multiple
process improvements in CD8-targeted fusosome manufacturing that
enhance fusosome transduction of resting T cells in vitro and in
vivo, including in vitro and in vivo tumor killing.
- Presented the
development of a modular approach to generate fusosomes for
targeted gene delivery.
- AACR:
- Presented
preclinical data demonstrating that hypoimmune-modified CAR T cells
provide lasting tumor control in immunocompetent allogeneic
humanized mice even with tumor re-challenge.
- Presented
preclinical data in a late-breaking poster presentation
demonstrating that the increased potency of CD8-targeted fusosomes
enhances CAR transgene delivery to resting primary T cells.
- Presented
preclinical data demonstrating the effectiveness of Sana’s fully
human CD19 CAR delivered by CD8-targeted fusosomes in tumor killing
assays. These fusosomes led to similar levels of tumor control as
ex vivo generated CD19 CAR T cells.
- Presented
preclinical data demonstrating increased potency of CD8-targeted
fusosomes delivering a CD19 CAR with pre-treatment of resting T
cells with IL-7, rapamycin, or both. Pre-treatment with these
molecules led to increased anti-tumor efficacy through increased T
cell transduction and greater CAR T cell expansion.
Strengthened Research and Development
leadership with the appointment of two seasoned drug
developers
- Appointed Doug
Williams, Ph.D., as President of Research and Development. Dr.
Williams has over 30 years of experience leading R&D
organizations – including at Biogen, Seattle Genetics (now Seagen),
Amgen, and Immunex – and over the course of his career has
participated in the development of over a dozen approved drugs
including multiple blockbusters.
- Appointed Gary
Meininger, M.D., as Chief Medical Officer. Dr. Meininger has
approximately 20 years of experience in drug development. Most
recently, he was at Vertex as Senior Vice President, Head of
Clinical Development for Vertex Cell and Genetic Therapies and
previously was at Janssen and Merck. Dr. Meininger is currently the
industry representative to the FDA’s Endocrine and Metabolic Drug
Advisory Committee.
Second Quarter 2023 Financial
Results
GAAP Results
- Cash
Position: Cash, cash equivalents, and marketable
securities as of June 30, 2023 were $325.9 million compared to
$434.0 million as of December 31, 2022. The decrease of $108.1
million was primarily driven by cash used in operations of $138.1
million and cash used for the purchase of property and equipment of
$3.7 million. The decrease in cash was offset by net proceeds of
$27.0 million from at the market equity offerings during the six
months ended June 30, 2023.
- Research
and Development Expenses: For the three and six months
ended June 30, 2023, research and development expenses, inclusive
of non-cash expenses, were $73.0 million and $140.2 million,
respectively, compared to $72.5 million and $145.2 million for the
same periods in 2022. The increase of $0.5 million for the three
months ended June 30, 2023 compared to the same period in 2022 was
primarily due to an increase in clinical development costs,
non-cash lease costs for our planned manufacturing facility in
Bothell, Washington (the Bothell facility), personnel-related
costs, and depreciation expense. These increases were partially
offset by a decrease in costs for laboratory supplies, third-party
manufacturing costs, and costs related to the previously planned
manufacturing facility in Fremont, California (the Fremont
facility) that are now included in general and administrative
expense. The decrease of $5.0 million for the six months ended June
30, 2023 compared to the same period in 2022 was primarily due to a
decline in costs to acquire technology, laboratory supplies,
third-party manufacturing, and costs related to the Fremont
facility that are now included in general and administrative
expense. These decreases were partially offset by increased
clinical development costs, personnel-related costs, non-cash lease
costs for the Bothell facility, depreciation expense, and other
allocated costs. Research and development expenses include non-cash
stock-based compensation of $6.7 million and $12.7 million,
respectively, for the three and six months ended June 30, 2023, and
$7.4 million and $13.1 million, for the same periods in 2022.
- Research
and Development Related Success Payments and Contingent
Consideration: For the three and six months ended June 30,
2023, we recognized expenses of $26.7 million and $26.8 million,
respectively, in connection with the change in the estimated fair
value of the success payment liabilities and contingent
consideration in aggregate, compared to gains of $17.9 million and
$73.4 million for the same periods in 2022. The value of these
potential liabilities may fluctuate significantly with changes in
Sana’s market capitalization and stock price.
- General and
Administrative Expenses: General and administrative
expenses for the three and six months ended June 30, 2023,
inclusive of non-cash expenses, were $16.6 million and $33.3
million, respectively, compared to $18.3 million and $32.7 million
for the same periods in 2022. The decrease of $1.7 million for the
three months ended June 30, 2023 compared to the same period in
2022 was primarily due to the write-off of construction in progress
costs in 2022 for the Fremont facility, partially offset by an
increase in legal fees, non-cash stock-based compensation, and
costs related to the Fremont facility, formerly in research and
development expense. The increase of $0.6 million for the six
months ended June 30, 2023 compared to the same period in 2022 was
primarily due to an increase in personnel-related costs including
non-cash stock-based compensation, costs related to the Fremont
facility, formerly in research and development expense, and legal
fees, partially offset by the write-off of construction in progress
costs for the Fremont facility.
- Net
Loss: Net loss for the three and six months ended June 30,
2023 was $114.0 million, or $0.59 per share, and $196.1 million, or
$1.02 per share, respectively, compared to $72.5 million, or $0.39
per share, and $103.9, or $0.56 per share for the same periods in
2022.
Non-GAAP Measures
- Non-GAAP
Operating Cash Burn: Non-GAAP operating cash burn for the
six months ended June 30, 2023 was $136.5 million compared to
$155.4 million for the same period in 2022. Non-GAAP operating cash
burn is the decrease in cash, cash equivalents, and marketable
securities, excluding cash inflows from financing activities, cash
outflows from business development, non-recurring items, and the
purchase of property and equipment.
- Non-GAAP
General and Administrative Expenses: Non-GAAP general and
administrative expenses for the three and six months ended June 30,
2023 was $16.6 million and $33.3 million, respectively, compared to
$13.8 million and $28.3 million for the same periods in 2022.
Non-GAAP general and administrative expense excludes the write-off
of construction in progress costs incurred in connection with the
Fremont facility.
- Non-GAAP
Net Loss: Non-GAAP net loss for the three and six months
ended June 30, 2023 was $87.3 million, or $0.45 per share, and
$169.3 million, or $0.88 per share, respectively, compared to $85.9
million, or $0.47 per share, and $172.8 million, or $0.93 per share
for the same periods in 2022. Non-GAAP net loss excludes non-cash
expenses related to the change in the estimated fair value of
contingent consideration and success payment liabilities.
A discussion of non-GAAP measures, including a
reconciliation of GAAP and non-GAAP measures, is presented below
under “Non-GAAP Financial Measures.”
About Sana
Sana Biotechnology, Inc. is focused on creating
and delivering engineered cells as medicines for patients. We share
a vision of repairing and controlling genes, replacing missing or
damaged cells, and making our therapies broadly available to
patients. We are a passionate group of people working together to
create an enduring company that changes how the world treats
disease. Sana has operations in Seattle, Cambridge, South San
Francisco, and Rochester.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements about Sana Biotechnology, Inc. (the “Company,” “we,”
“us,” or “our”) within the meaning of the federal securities laws,
including those related to the company’s vision, progress, and
business plans; expectations for its development programs, product
candidates and technology platforms, including its preclinical,
clinical and regulatory development plans and timing expectations,
including the expected timing of IND filings and clinical trials
for the Company’s product candidates and indications for which such
INDs will be filed; expectations regarding the timing, substance,
and impact of data from clinical trials of the Company’s product
candidates and an investigator-sponsored trial utilizing
hypoimmune-modified primary human islet cells in type 1 diabetes
patients (the “IST”); expectations regarding the Company’s
participation at scientific conferences; the potential ability of
SC291 to serve as clinical proof-of-platform for the Company’s
other hypoimmune-modified CAR T cell candidates; expectations with
respect to the potential therapeutic benefits and impact of its
development programs and platforms, including the potential ability
of the hypoimmune platform to overcome immunologic rejection of
allogeneic cells and the impact thereof, the potential for
hypoimmune-modified islet cells to demonstrate allogeneic immune
evasion, autoimmune evasion, and control of type 1 diabetes, and
the potential ability to replace missing islet cells without
immunosuppression in patients with type 1 diabetes; expectations
regarding the IST, including the ability to initiate the IST and
the potential of the IST to show cell survival and immune evasion
without immunosuppression; the potential ability of preclinical
data to provide insight for the Company’s development programs and
platforms; and expectations regarding the Company’s capital
position, resources, and balance sheet and the potential impact
thereof on the Company’s development programs, including data
readouts from such programs. All statements other than statements
of historical facts contained in this press release, including,
among others, statements regarding the Company’s strategy,
expectations, cash runway and future financial condition, future
operations, and prospects, are forward-looking statements. In some
cases, you can identify forward-looking statements by terminology
such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,”
“continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,”
“intend,” “may,” “objective,” “plan,” “positioned,” “potential,”
“predict,” “seek,” “should,” “target,” “will,” “would” and other
similar expressions that are predictions of or indicate future
events and future trends, or the negative of these terms or other
comparable terminology. The Company has based these forward-looking
statements largely on its current expectations, estimates,
forecasts and projections about future events and financial trends
that it believes may affect its financial condition, results of
operations, business strategy and financial needs. In light of the
significant uncertainties in these forward-looking statements, you
should not rely upon forward-looking statements as predictions of
future events. These statements are subject to risks and
uncertainties that could cause the actual results to vary
materially, including, among others, the risks inherent in drug
development such as those associated with the initiation, cost,
timing, progress and results of the Company’s current and future
research and development programs, preclinical and clinical trials,
as well as economic, market, and social disruptions. For a detailed
discussion of the risk factors that could affect the Company’s
actual results, please refer to the risk factors identified in the
Company’s Securities and Exchange Commission (SEC) reports,
including but not limited to its Quarterly Report on Form 10-Q
dated August 3, 2023. Except as required by law, the Company
undertakes no obligation to update publicly any forward-looking
statements for any reason.
Investor Relations & Media:Nicole
Keithinvestor.relations@sana.com media@sana.com
Sana Biotechnology,
Inc.Unaudited Selected Consolidated Balance Sheet
Data
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(in thousands) |
|
Cash, cash equivalents, and marketable securities |
|
$ |
325,915 |
|
|
$ |
434,014 |
|
Total assets |
|
|
707,147 |
|
|
|
822,720 |
|
Contingent consideration |
|
|
161,734 |
|
|
|
150,379 |
|
Success payment liabilities |
|
|
36,451 |
|
|
|
21,007 |
|
Total liabilities |
|
|
352,118 |
|
|
|
323,405 |
|
Total stockholders' equity |
|
|
355,029 |
|
|
|
499,315 |
|
|
|
|
|
|
|
|
|
|
Sana Biotechnology,
Inc.Unaudited Consolidated Statements of
Operations
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands, except per share data) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
73,044 |
|
|
$ |
72,540 |
|
|
$ |
140,210 |
|
|
$ |
145,229 |
|
Research and development related success payments and contingent
consideration |
|
|
26,679 |
|
|
|
(17,928 |
) |
|
|
26,799 |
|
|
|
(73,366 |
) |
General and administrative |
|
|
16,566 |
|
|
|
18,292 |
|
|
|
33,332 |
|
|
|
32,726 |
|
Total operating expenses |
|
|
116,289 |
|
|
|
72,904 |
|
|
|
200,341 |
|
|
|
104,589 |
|
Loss from operations |
|
|
(116,289 |
) |
|
|
(72,904 |
) |
|
|
(200,341 |
) |
|
|
(104,589 |
) |
Interest income, net |
|
|
2,374 |
|
|
|
637 |
|
|
|
4,350 |
|
|
|
976 |
|
Other expense, net |
|
|
(84 |
) |
|
|
(198 |
) |
|
|
(131 |
) |
|
|
(300 |
) |
Net loss |
|
$ |
(113,999 |
) |
|
$ |
(72,465 |
) |
|
$ |
(196,122 |
) |
|
$ |
(103,913 |
) |
Net loss per common share -
basic and diluted |
|
$ |
(0.59 |
) |
|
$ |
(0.39 |
) |
|
$ |
(1.02 |
) |
|
$ |
(0.56 |
) |
Weighted-average number of
common shares - basic and diluted |
|
|
192,540 |
|
|
|
187,626 |
|
|
|
191,888 |
|
|
|
186,801 |
|
|
Sana Biotechnology,
Inc.Changes in the Estimated Fair Value of Success
Payments and Contingent Consideration
|
|
Success
PaymentLiability(1) |
|
|
ContingentConsideration(2) |
|
|
Total Success Payment Liability and Contingent
Consideration |
|
|
|
(in thousands) |
|
Liability balance as of December 31, 2022 |
|
$ |
21,007 |
|
|
$ |
150,379 |
|
|
$ |
171,386 |
|
Changes in fair value - expense (gain) |
|
|
(5,340 |
) |
|
|
5,460 |
|
|
|
120 |
|
Liability balance as of March 31,
2023 |
|
|
15,667 |
|
|
|
155,839 |
|
|
|
171,506 |
|
Changes in fair value - expense |
|
|
20,784 |
|
|
|
5,895 |
|
|
|
26,679 |
|
Liability balance as of June 30,
2023 |
|
|
36,451 |
|
|
|
161,734 |
|
|
|
198,185 |
|
Total change in fair value for
the six months ended June 30, 2023 |
|
$ |
15,444 |
|
|
$ |
11,355 |
|
|
$ |
26,799 |
|
(1) |
|
Cobalt Biomedicine, Inc. (Cobalt) and the Presidents of Harvard
College (Harvard) are entitled to success payments pursuant to the
terms and conditions of their respective agreements. The success
payments are recorded at fair value and remeasured at each
reporting period with changes in the estimated fair value recorded
in research and development related success payments and contingent
consideration on the statement of operations. |
(2) |
|
Cobalt is entitled to contingent consideration upon the achievement
of certain milestones pursuant to the terms and conditions of the
agreement. Contingent consideration is recorded at fair value and
remeasured at each reporting period with changes in the estimated
fair value recorded in research and development related success
payments and contingent consideration on the statement of
operations. |
Non-GAAP Financial Measures
To supplement the financial results presented in
accordance with generally accepted accounting principles in the
United States (GAAP), Sana uses certain non-GAAP financial measures
to evaluate its business. Sana’s management believes that these
non-GAAP financial measures are helpful in understanding Sana’s
financial performance and potential future results, as well as
providing comparability to peer companies and period over period.
In particular, Sana’s management utilizes non-GAAP operating cash
burn, non-GAAP research and development expense and non-GAAP net
loss and net loss per share. Sana believes the presentation of
these non-GAAP measures provides management and investors greater
visibility into the company’s actual ongoing costs to operate its
business, including actual research and development costs
unaffected by non-cash valuation changes and certain one-time
expenses for acquiring technology, as well as facilitating a more
meaningful comparison of period-to-period activity. Sana excludes
these items because they are highly variable from period to period
and, in respect of the non-cash expenses, provides investors with
insight into the actual cash investment in the development of its
therapeutic programs and platform technologies.
These are not meant to be considered in
isolation or as a substitute for comparable GAAP measures and
should be read in conjunction with Sana’s financial statements
prepared in accordance with GAAP. These non-GAAP measures differ
from GAAP measures with the same captions, may be different from
non-GAAP financial measures with the same or similar captions that
are used by other companies, and do not reflect a comprehensive
system of accounting. Sana’s management uses these supplemental
non-GAAP financial measures internally to understand, manage, and
evaluate Sana’s business and make operating decisions. In addition,
Sana’s management believes that the presentation of these non-GAAP
financial measures is useful to investors because they enhance the
ability of investors to compare Sana’s results from period to
period and allows for greater transparency with respect to key
financial metrics Sana uses in making operating decisions. The
following are reconciliations of GAAP to non-GAAP financial
measures:
Sana Biotechnology,
Inc.Unaudited Reconciliation of Change in Cash,
Cash Equivalents, and Marketable Securities
toNon-GAAP Operating Cash Burn
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands) |
|
Beginning cash, cash equivalents, and marketable securities |
|
$ |
434,014 |
|
|
$ |
746,877 |
|
Ending cash, cash equivalents,
and marketable securities |
|
|
325,915 |
|
|
|
579,566 |
|
Change in cash, cash
equivalents, and marketable securities |
|
|
(108,099 |
) |
|
|
(167,311 |
) |
Cash paid to purchase property and equipment |
|
|
3,753 |
|
|
|
11,924 |
|
Change in cash, cash
equivalents, and marketable securities, excluding capital
expenditures |
|
|
(104,346 |
) |
|
|
(155,387 |
) |
Adjustments: |
|
|
|
|
|
|
Net proceeds from issuance of common stock(1) |
|
|
(27,014 |
) |
|
|
- |
|
Cash paid for restructuring(2) |
|
|
1,881 |
|
|
|
- |
|
Cash received in connection with the Coronavirus Aid, Relief, and
Economic Security Act |
|
|
(7,063 |
) |
|
|
- |
|
Operating cash burn -
Non-GAAP |
|
$ |
(136,542 |
) |
|
$ |
(155,387 |
) |
(1) |
|
Net proceeds of $27.0 million
were received in connection with at market equity offerings in the
six months ended June 30, 2023. |
(2) |
|
The non-GAAP adjustment of $1.8
million for the six months ended June 30, 2023 consisted of cash
payments related to the portfolio prioritization and corporate
restructuring in the fourth quarter of 2022. |
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
General and Administrative Expense
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands) |
|
General and administrative - GAAP |
|
$ |
16,566 |
|
|
$ |
18,292 |
|
|
$ |
33,332 |
|
|
$ |
32,726 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Write-off of construction in progress costs incurred in connection
with the Fremont facility |
|
|
- |
|
|
|
(4,474 |
) |
|
|
- |
|
|
|
(4,474 |
) |
General and administrative -
Non-GAAP |
|
$ |
16,566 |
|
|
$ |
13,818 |
|
|
$ |
33,332 |
|
|
$ |
28,252 |
|
|
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
Net Loss and Net Loss Per Share
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands, except per share data) |
|
Net loss - GAAP |
|
$ |
(113,999 |
) |
|
$ |
(72,465 |
) |
|
$ |
(196,122 |
) |
|
$ |
(103,913 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
|
20,784 |
|
|
|
(14,098 |
) |
|
|
15,444 |
|
|
|
(69,008 |
) |
Change in the estimated fair value of contingent
consideration(2) |
|
|
5,895 |
|
|
|
(3,830 |
) |
|
|
11,355 |
|
|
|
(4,358 |
) |
Write-off of construction in progress costs incurred in connection
with the Fremont facility |
|
|
- |
|
|
|
4,474 |
|
|
|
- |
|
|
|
4,474 |
|
Net loss - Non-GAAP |
|
$ |
(87,320 |
) |
|
$ |
(85,919 |
) |
|
$ |
(169,323 |
) |
|
$ |
(172,805 |
) |
Net loss per share - GAAP |
|
$ |
(0.59 |
) |
|
$ |
(0.39 |
) |
|
$ |
(1.02 |
) |
|
$ |
(0.56 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
|
0.11 |
|
|
|
(0.08 |
) |
|
|
0.08 |
|
|
|
(0.37 |
) |
Change in the estimated fair value of contingent
consideration(2) |
|
|
0.03 |
|
|
|
(0.02 |
) |
|
|
0.06 |
|
|
|
(0.02 |
) |
Write-off of construction in progress costs incurred in connection
with the Fremont facility |
|
|
- |
|
|
|
0.02 |
|
|
|
- |
|
|
|
0.02 |
|
Net loss per share -
Non-GAAP |
|
$ |
(0.45 |
) |
|
$ |
(0.47 |
) |
|
$ |
(0.88 |
) |
|
$ |
(0.93 |
) |
Weighted-average shares
outstanding - basic and diluted |
|
|
192,540 |
|
|
|
187,626 |
|
|
|
191,888 |
|
|
|
186,801 |
|
(1) |
|
For the three and six months
ended June 30, 2023, the expenses related to the Cobalt success
payment liability were $18.5 million and $13.7 million,
respectively, compared to gains of $12.1 million and $58.9 million,
respectively, for the same periods in 2022. For the three and six
months ended June 30, 2023, the expenses related to the Harvard
success payment liability were $2.3 million and $1.7 million,
respectively, compared to gains of $2.0 million and 10.1 million,
respectively, for the same periods in 2022. |
(2) |
|
The contingent consideration is
in connection with the acquisition of Cobalt. |
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